Latest News on RPS Version 2
- Is general enough to handle all regulated products such as drugs, biologics, medical devices, vet meds, combination products and food products
- Allows sponsors to send regulatory information using predefined parameters to identify and catalog their content
- Provides enough information to allow regulators to support structured review by providing the ability to consistently locate specific information
July’s kickoff meeting was attended by over 50 representatives from the FDA, EMEA, Health Canada, MEB, PMDA, and a number of vendors and pharma companies, despite significant weather issues that caused flight delays and cancellations. The focus of the kickoff meeting was on requirements gathering and further refinements to scope (there is already a project scope statement, but it could benefit from more input from outside the US).
The group broke up into around eight teams to refine and add to specific requirements topics. Topics included Two-Way/Communicate Regulatory Action, Referencing/Within Docs/to External Warehouse, Forms Data, and several others.
Next steps for the initiative include:
- Determining how to organize sub groups. Formation of a leadership team and organization of a development team, a testing team, etc. are being discussed. Issues around leadership (such as determining how decisions are made and who is responsible for what aspects) are especially important.
- Continuing to push forward with requirements. FDA has PDUFA imposed deadline of September 2012 for implemenation of RPS 2, so consistent progress is essential.
Progress is being made through ongoing meetings. A biweekly meeting is held (on a rotating schedule to accomodate participants from time zones all over the world) to advance requirements. A weekly leadership currently has a focus on infrastructure and subgroups – progress on organizing the testing group being especially important right now.
If you would like to stay informed on RPS,you can receive updates via a list service by registering at Health Level 7 – Subscribe to List Services. Upcoming meetings and other events will be announced via the list service, and you can still participate in these meetings and events – membership and participation are not limited to a closed group.